Home NDC 50844-519 Pain Reliever
Product NDC 50844-519
11-digit product format 508440519
Labeler code 50844
Product ID 50844-519_9f5e3344-4f7b-4096-a4f0-929e140c175c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-05-10
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pain Reliever
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50844-519-02 Pain RelieverExtra Strength 12 in 1 BOTTLE, PLASTIC TABLET, COATED 12 17 50844-519-02 Pain RelieverExtra Strength 1 in 1 CARTON TABLET, COATED 1 17 50844-519-12 Pain RelieverExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 17 50844-519-15 Pain RelieverExtra Strength 1 in 1 CARTON TABLET, COATED 1 17 50844-519-15 Pain RelieverExtra Strength 50 in 1 BOTTLE TABLET, COATED 50 17 50844-519-20 Pain RelieverExtra Strength 225 in 1 BOTTLE, PLASTIC TABLET, COATED 225 17 50844-519-21 Pain RelieverExtra Strength 1 in 1 CARTON TABLET, COATED 1 17 50844-519-21 Pain RelieverExtra Strength 16 in 1 BOTTLE, PLASTIC TABLET, COATED 16 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-519 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.] 16 Current NDC, Legacy NDC, 8 package rows 20241109_72babe91-2586-4f05-ae90-6debfd23aa5d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 56 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Publix Fast Relief Effervescent ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Publix Super Markets Inc. 73051f16-2569-7394-e053-2991aa0a5359 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Effervescent Antacid and Pain Relief ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 70d265de-ff94-e0e4-e053-2a91aa0a962a 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Extra Strength Effervescent Antacid and Pain Relief ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 9f7d0c96-a561-a8a0-e053-2995a90a250b 2024-11-13 Warnings Exact identifier application number: M013 WinCo Foods Effervescent Antacid and Pain Relief ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET WinCo Foods, LLC 0c8a755a-089f-477f-97e9-0dd6fdfbe99d 2024-11-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Kroger Company 8fb19444-f0e0-4d26-81e8-6a4b835056d8 2024-11-12 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN WALMART INC. 59d01f72-4575-48e2-b914-b6a6456ca7d2 2024-11-11 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Kroger Company d181560c-1c39-4f2e-8a17-996224ca040f 2024-11-09 Warnings Exact identifier application number: M013 Childrens Tylenol ACETAMINOPHEN Kenvue Brands LLC babcb210-6a47-46ef-b4ea-bdde80411cd3 2024-11-08 Warnings Exact identifier application number: M013 Bayer Genuine Aspirin ASPIRIN Acme United Corporation f7f9dc46-a945-7ae3-e053-6394a90a1192 2024-11-08 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC dd87e342-b0cb-4111-9f15-415dbcda4b77 2024-11-07 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 0c5fdda8-5049-46de-e063-6294a90a592b 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 46ddbfde-54ab-4373-b832-b9c0620b1e9d 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 333f6231-3778-4c1f-9558-2afddca22c86 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 34247a3b-0846-4086-becd-76e630b3b721 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC a51c2deb-c703-4dc8-9255-8ac9fe635170 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC ce0a1fbc-7345-462b-b0da-c7149bdc288c 2024-11-07 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 015a6179-bacb-452d-b594-4de628ddc11d 2024-11-07 Warnings Exact identifier application number: M013 TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC de5c6654-56c5-40d3-a286-f04ed47ac7c8 2024-11-07 Warnings Exact identifier application number: M013 Midol Complete ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE Acme United Corporation f7bf126d-a6f1-231a-e053-6294a90a04e1 2024-11-07 Warnings Exact identifier application number: M013 CareOne Childrens Acetaminophen ACETAMINOPHEN American Sales Company 49021ae8-9655-4885-9f74-52df4cdcb26f 2024-11-07 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50844-519-02 50844051902 1 BOTTLE, PLASTIC in 1 CARTON (50844-519-02) > 12 TABLET, COATED in 1 BOTTLE, PLASTIC 2004-05-10 0000-00-00 No No Current 50844-519-12 50844051912 100 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-12) 2023-11-14 No No Current 50844-519-15 50844051915 1 BOTTLE in 1 CARTON (50844-519-15) > 50 TABLET in 1 BOTTLE 1 bottle 2004-05-10 0000-00-00 No No Current 50844-519-20 50844051920 225 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-20) 2023-11-14 No No Current 50844-519-21 50844051921 1 BOTTLE, PLASTIC in 1 CARTON (50844-519-21) / 16 TABLET, COATED in 1 BOTTLE, PLASTIC 2004-05-10 0000-00-00 No No Current